Daltex – Medicinal Product Register of Latvia

Vildagliptinum, Metformini hydrochloridum

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Medicinal product name	Daltex 50 mg/1000 mg film-coated tablets
Pharmaceutical form	Film-coated tablet
Strength	50 mg/1000 mg
Information from the MAH on shortages	No information on expected shortages
Legal status	Rx Prescription (Pr.) KZSL Next lowest cost medicine
Package leaflet	30-11-2023
Summary of product characteristics	30-11-2023
ATC code	A10BD08 – Drugs used in diabetes
Information for Marketing authorisation holders	View

Product information leaflet and summary of product characteristics in MS Word format.

Package leaflet	30-11-2023
Summary of product characteristics	30-11-2023

Medicinal products (6)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (50 mg/1000 mg)	Al/Al blister		17-0208-01	Labelling text May 31, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (50 mg/1000 mg)	Al/Al blister		17-0208-02	Labelling text May 31, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N60 (50 mg/1000 mg)	Al/Al blister	€ 23.14 KZSL*	17-0208-03	Labelling text May 31, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N120 (50 mg/1000 mg)	Al/Al blister		17-0208-04	Labelling text May 31, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N180 (50 mg/1000 mg)	Al/Al blister		17-0208-05	Labelling text May 31, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N360 (50 mg/1000 mg)	Al/Al blister		17-0208-06	Labelling text May 31, 2018

* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No.	17-0208
Date of authorisation	Sep 11, 2017
Marketing authorisation holder, country	Medochemie Ltd., Cyprus

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on Apr 17, 2024.